Phase 2
Completed N=80
Trial to Assess the Safety and Tolerability of Lucinactant for Inhalation in Premature Neonates
Source: ClinicalTrials.gov NCT02074059 ↗Enrolled (actual)
80
Serious AEs
25.0%
Results posted
Apr 2017
Primary outcomePrimary: Peri-Dosing Events — 0; 0; 0; 1 participants
Summary
The primary objective of this study is to evaluate the safety and tolerability of aerosolized surfactant, specifically lucinactant for inhalation, administered in escalating inhaled doses to preterm neonates 29 to 34 weeks gestational age who are receiving nasal continuous positive airway pressure (nCPAP) for respiratory distress syndrome (RDS), compared to neonates receiving nCPAP alone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peri-Dosing Events |
0; 0; 0; 1; 0; 2 | — |
| PRIMARY All Cause Mortality |
0; 0; 0; 0; 1; 1 | — |
| PRIMARY Oxygen Saturation Levels |
94.0; 91.3; 96.4; 93.9; 92.5; 93.3 | — |
| PRIMARY Serum Electrolytes |
140; 137; 139; 140; 137; 139 | — |
| SECONDARY PCO2 |
58.0; 54.3; 47.1; 49.6; 57.4; 49.2 | — |
Eligibility Criteria
Inclusion Criteria
- Informed consent from a legally authorized representative
- Gestational age 29 to 34 completed weeks (34 weeks 6 days) post menstrual age (PMA)
- Successful implementation of controlled nCPAP within 90 minutes after birth
- Spontaneous breathing
- Chest radiograph consistent with RDS
- Need for moderate levels of supplemental oxygen and nCPAP to maintain oxygen saturation of 88% to 95% for at least 30 minutes within the first 21 hours after birth
Exclusion Criteria
- Heart rate that cannot be stabilized above 100 beats/minute within 5 minutes of birth
- Recurrent episodes of apnea occurring after the initial newborn resuscitation period (ie, 10 minutes after birth) requiring intermittent positive pressure breaths using inflating pressures above the set CPAP pressure administered manually or mechanically through any patient interface
- A 5 minute Apgar score 2 weeks
- Evidence of hemodynamic instability requiring vasopressors or steroids for hemodynamic support and/or presumed clinical sepsis
- Need for endotracheal intubation and mechanical ventilation
- Has been administered: another investigational agent or exposure to an investigational medical device, any other surfactant agent, steroid treatment after birth
Data sourced from ClinicalTrials.gov (NCT02074059). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.